The following data is part of a premarket notification filed by Thermo Fisher Scientific Oy with the FDA for Alkaline Phosphatase (ifcc) Plus, Ecal, Nortrol, Abtrol.
| Device ID | K073191 |
| 510k Number | K073191 |
| Device Name: | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | THERMO FISHER SCIENTIFIC OY 2 RATASTIE Vantaa, FI 01620 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen THERMO FISHER SCIENTIFIC OY 2 RATASTIE Vantaa, FI 01620 |
| Product Code | CJE |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JIY |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2008-02-28 |
| Summary: | summary |